Breast Neoplasm Female, Mastectomy, Segmental
Conditions
Brief summary
HaemoCer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. There is however no adequate data available on the efficacy of HaemoCer regarding seroma formation or drainage output. The objective of this study is to investigate whether the intraoperative application of haemostatic powder (HaemoCer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).
Interventions
OTHERHaemoCer
Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with breast cancer undergoing breast-conserving surgery * No previous breast-conserving surgery on the same site * ≥ 18 years age * no current pregnancy * Informed consent
Exclusion criteria
Patients with previous breast-conserving surgery on the same site \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total volume of postoperative drained fluid (per breast) | 7 days |
| Number of days until drain removal (n) | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection) | 7 days |
| Rate of immediate postoperative infection on the breast surgery site | 7 days |
Countries
Austria
Outcome results
None listed